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Trial registered on ANZCTR


Registration number
ACTRN12621001094864
Ethics application status
Approved
Date submitted
24/06/2021
Date registered
18/08/2021
Date last updated
18/08/2021
Date data sharing statement initially provided
18/08/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Workplace evaluation of online procedures to manage risk of both musculoskeletal and stress-related mental health disorders.
Scientific title
Workplace evaluation of online procedures to manage risk of both musculoskeletal and stress-related mental health disorders in manufacturing workers.
Secondary ID [1] 304468 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
work-related musculoskeletal disorders 322297 0
Work-related mental health disorders 322298 0
Condition category
Condition code
Public Health 319972 319972 0 0
Other public health
Musculoskeletal 320403 320403 0 0
Other muscular and skeletal disorders
Mental Health 320404 320404 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention sites will implement the toolkit in their workplace. The toolkit implementation is a 12 month cycle of identifying hazards and developing actions to address hazards. This will be part of their normal occupational health and safety management system. The research team will be attending the monthly RMT meetings and maintain regular contact with the intervention sites to ensure implementation progresses smoothly.

The toolkit was designed to enable comprehensive diagnosis of the unique musculoskeletal disorder (MSD) hazard profiles of different jobs, based on results from a survey covering both physical and psychosocial hazards and an MSD risk indicator. Workers participate in developing risk control actions that are customised to their job’s specific hazard profile and that accord with the risk control hierarchy, following online guidance. To promote its uptake and sustainable use in ordinary workplaces, the toolkit was formulated in accord with a framework developed by the World Health Organisation and follows implementation science principles as summarised in the Quality Implementation Framework. For further details see www.aphirm.org.au.

As part of the toolkit implementation, workplaces establish a Risk Management Team (RMT) to oversee implementation. The RMT oversees the implementation of the toolkit in a designated workgroup (20-30 workers x 3 workgroups) and consists of managers, supervisors and workers in the designated workgroup. They will meet monthly for approximately 1 hour, with an additional meeting required during the 'create action plan' stage. They are guided by the toolkit’s interactive online procedures through the following steps, repeating this cycle annually:

1. Hazard identification (anonymous online survey of workers to quantify MSD risk level in terms of a validated discomfort/ pain score, stress measure, and the self-reported incidence of any absence from work due to MSD pain, as well as severity of each of a comprehensive set of work-related physical and psychosocial hazards). The online survey takes approximately 15mins and occurs within the first few weeks of toolkit implementation. The toolkit automatically determines the top 10 hazards.

2. Identification of causes and solutions for each of the top 10 hazards (a second online survey completed by workers - taking approx. 15 mins). This will occur approximately 2 weeks after the first survey - timing will be dependant on operation/production demands within the participating business.

3. Action plan drafted by RMT, based on step 2. The RMT will need to meet twice, (1.5hrs per meeting) to complete this step. The drafting of the action plan will commence within two weeks of receiving the second survey responses however, the timing of the RMT meeting will depend on demands and staff availability within participating businesses. Examples of actions to be implemented include staffing changes, the introduction of new equipment, changes to rostering systems. It is expected the implementation of the action plan will occur within 8 weeks following the collection of data from the identification of causes/solutions survey.

4. Monitor and evaluate resultant actions and changes through ongoing monthly meetings & communication with designated workgroup. Workers will complete an online survey (review feedback survey) at the end of the 12 month cycle to provide feedback on the helpfulness of each action (10 mins).

5. Evaluate outcomes, based primarily on a comparison of initially measured MSD risk and hazard profiles with those measured 12 months after implementation of the toolkit. At the end of the 12-month cycle, workers complete the online hazard survey so that a comparison can be made to the initial survey results. This is a separate survey from the online review feedback survey.
Intervention code [1] 320818 0
Prevention
Comparator / control treatment
The control group consists of organisations that will not be implementing the toolkit. They will be undertaking their usual MSD risk management practices. Usual risk management practices vary greatly between organisations and may include hazard identification strategies (e.g. checklists), incident reporting & investigation procedures, and risk assessment strategies (e.g., expert observation, consultation with workers). Control sites will undertake a baseline hazard identification survey and then follow up at 12 months. At the completion of the project, the control sites have the option to implement the toolkit which is freely available online.
Control group
Active

Outcomes
Primary outcome [1] 327846 0
Physical hazard scores are a component of the toolkit and calculated using an algorithm that is built into the software.

The questions used to determine hazard ratings are sourced from: Work Organisation Assessment Questionnaire (WOAQ) (Griffiths A, Cox T, Karanika M, Khan S, Tomas JM. Work design and managmeent in the manufatcuring sector: development and validation of the Work Organisation Assessment Questionnaire. Occupational Environmental Medicine. 2006;63(10):669–675). Job Content Questionnaire (Karasek R, Brisson C, Kawakami N, Houtman I, Bongers P, Amick B. The Job Content Questionnaire (JCQ): an instrument for internationally comparative assessments of psychosocial job characteristics. Journal of Occupational Health Psychology. 1998;3(4):322.]), the Job Diagnostic Survey (Hackman JR, Oldham GR. Development of the job diagnostic survey. Journal of Applied Psychology. 1975:60(2):159.]), a Work Characteristics survey (Marlow P, Pinder A, Gould V. Benchmarking manual handling performance in Welsh care homes. 2005. http://library.safework.sa.gov.au/fullRecord.jsp?recnoListAttr=recnoList&recno=33702.), and our previous research on effects of highly repetitive, externally-paced work on employee wellbeing (Macdonald, W.A. 2000. Workload, fatigue and job satisfaction in repetitive blue-collar work. In Human System Interaction: Education, Research and Application in the 21st Century, edited de Waard et al, Shaker Publishing BV, Maastricht, The Netherlands), (Macdonald, W. 2003. Work demands and stress in repetitive ‘blue-collar’ work. In Work Stress: Studies of the context, content and outcomes of stress. A Book of Readings. Chapter 7 (pp.139-163). Baywood: New York.).
Timepoint [1] 327846 0
This outcome will be assessed at baseline, and again in 12 month's time (following the completion of the intervention.)
Primary outcome [2] 327847 0
Psychosocial hazard scores are a component of the toolkit and calculated using an algorithm that is built into the software.
The questions used to determine hazard ratings are sourced from: Copenhagen Psychosocial Questionnaire (Kristensen, Tage & Hannerz, Harald & Hogh, Annie & Borg, Vilhelm. (2006). The Copenhagen Psychosocial Questionnaire - A tool for the assessment and improvement of the psychosocial work environment. Scandinavian journal of work, environment & health. 31. 438-49. 10.5271/sjweh.948.)
Timepoint [2] 327847 0
This outcome will be assessed at baseline, and again in 12 month's time (following the completion of the intervention.)
Secondary outcome [1] 396760 0
Musculoskeletal pain score is used to assess musculoskeletal pain and is derived from the Nordic Musculoskeletal Questionnaire (Joanne O. Crawford, The Nordic Musculoskeletal Questionnaire, Occupational Medicine, Volume 57, Issue 4, June 2007, Pages 300–301, https://doi.org/10.1093/occmed/kqm036).
Timepoint [1] 396760 0
This outcome will be assessed at baseline, and again in 12 month's time (following the completion of the intervention.)
Secondary outcome [2] 397339 0
Stress score will be assessed using Copenhagen Psychosocial Questionnaire (Kristensen, Tage & Hannerz, Harald & Hogh, Annie & Borg, Vilhelm. (2006). The Copenhagen Psychosocial Questionnaire - A tool for the assessment and improvement of the psychosocial work environment. Scandinavian journal of work, environment & health. 31. 438-49. 10.5271/sjweh.948.).
Timepoint [2] 397339 0
This outcome will be assessed at baseline, and again in 12 month's time (following the completion of the intervention.)

Eligibility
Key inclusion criteria
This is an industry based trial focussed on high risk industry sectors of manufacturing and logistics. Businesses must be larger than 50 employees and based in the State of Victoria. Must be able to include 60 workers in different work groups of at least 15 employees.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Businesses were included in the study and allocated a number. An independent researcher received these numbers and assigned them using a random number allocator in excel as either the control or intervention group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A simple randomisation process was used in excel.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Given the data structure of participants within working groups within organisations (multilevel data), the results will be analysed with a mixed effects model. Power and sample size calculations were conducted in R (version 4.0.3 -- "Bunny-Wunnies Freak Out") to detect a change in physical demands between intervention and control of 0.5. We made the assumptions that the baseline physical demands in manufacturing would have a mean of 3.6 and an SD 0.8, The ICC was set conservatively at 0.05.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
28/05/2021
Date of last participant enrolment
Anticipated
30/08/2021
Actual
Date of last data collection
Anticipated
30/08/2022
Actual
Sample size
Target
360
Accrual to date
180
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 308826 0
Government body
Name [1] 308826 0
WorkSafe Victoria
Country [1] 308826 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
Kingsbury Drive, Bundoora, Victoria, 3086
Country
Australia
Secondary sponsor category [1] 309746 0
None
Name [1] 309746 0
None
Address [1] 309746 0
Country [1] 309746 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308739 0
La Trobe University Human Research Ethics Committee
Ethics committee address [1] 308739 0
Ethics committee country [1] 308739 0
Australia
Date submitted for ethics approval [1] 308739 0
17/02/2021
Approval date [1] 308739 0
15/03/2021
Ethics approval number [1] 308739 0
HEC21052

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 111722 0
A/Prof Jodi Oakman
Address 111722 0
La Trobe University, HS2, Kingsbury Drive, Bundoora, Victoria, 3086
Country 111722 0
Australia
Phone 111722 0
+61 03 94793235
Fax 111722 0
Email 111722 0
j.oakman@latrobe.edu.au
Contact person for public queries
Name 111723 0
Natasha Kinsman
Address 111723 0
La Trobe University, HS2, Kingsbury Drive, Bundoora, Victoria, 3086
Country 111723 0
Australia
Phone 111723 0
+61 03 94795392
Fax 111723 0
Email 111723 0
n.kinsman@latrobe.edu.au
Contact person for scientific queries
Name 111724 0
Jodi Oakman
Address 111724 0
La Trobe University, HS2, Kingsbury Drive, Bundoora, Victoria, 3086
Country 111724 0
Australia
Phone 111724 0
+61 03 94793235
Fax 111724 0
Email 111724 0
j.oakman@latrobe.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We do not have ethics approval to share the data.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.